Effectiveness of a Rehabilitation Program in Improving Quality of Life in Patients With Esophageal Cancer

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Recruiting

CT.gov ID

NCT03161535

Collaborator

(none)

175

Enrollment

Location

Arms

69.4

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will investigate the effectiveness of a rehabilitation program in improving sleep quality, emotional distress, circadian rhythms, and quality of life in patients with esophageal cancer in Taiwan.

Hypothesis:

The quality of life in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.
The quality of sleep in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.
The emotional distress in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.
The circadian rhythms in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Other: exercise and dietary education Other: weekly telephone consultations concerning exercise and diet.	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

175 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Effectiveness of a Rehabilitation Program in Improving Sleep Quality, Emotional Distress, Circadian Rhythms, and Quality of Life in Patients With Esophageal Cancer

Actual Study Start Date :

Sep 19, 2017

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: exercise group The rehabilitation program was composed of two parts: an exercise program and a diet-teaching program. The exercise program was a 12-week home-based program that comprised moderate-intensity brisk walking for 40 min per session, with 3 sessions per week; in addition, weekly exercise counseling was provided through telephone. The diet teaching program was provided to the patients by using a diet booklet at baseline (same timing as the exercise program), and its contents were used to instruct the patients regarding dietary principles to be followed.	Other: exercise and dietary education A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a week, was administered along with weekly exercise counseling. After collecting pretrial measurements, we explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. The detailed instructions, provided at the hospital clinics, included the determination of activity intensity, demonstration of pulse measurement, criteria for scores of 6-20 on the Borg's rating of perceived exertion (RPE), prevention of exercise-related injuries, and conditions necessitating termination of an exercise session. Participants were instructed that the exercises would be effective only if they reached 60%-80% of the target heart rate, as determined by the Karvonen method, and 13-15 on the RPE. Diet-teaching program (using dietary education booklet). Other: weekly telephone consultations concerning exercise and diet. For each participant, we discussed exercise regimen-related issues and diet weekly through the telephone. For instance, we discussed whether participants' exercise fulfilled the prescribed intensity, duration, or frequency and whether the participants experienced any adverse effects.
No Intervention: usual-care group The control group (CG) received usual care, whereas a nurse, the manager for esophageal cancer treatment, provided routine care, conducted follow-ups, and offered information on esophageal cancer to the experimental group (EG).

Arm

Intervention/Treatment

Experimental: exercise group

The rehabilitation program was composed of two parts: an exercise program and a diet-teaching program. The exercise program was a 12-week home-based program that comprised moderate-intensity brisk walking for 40 min per session, with 3 sessions per week; in addition, weekly exercise counseling was provided through telephone. The diet teaching program was provided to the patients by using a diet booklet at baseline (same timing as the exercise program), and its contents were used to instruct the patients regarding dietary principles to be followed.

Other: exercise and dietary education

A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a week, was administered along with weekly exercise counseling. After collecting pretrial measurements, we explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. The detailed instructions, provided at the hospital clinics, included the determination of activity intensity, demonstration of pulse measurement, criteria for scores of 6-20 on the Borg's rating of perceived exertion (RPE), prevention of exercise-related injuries, and conditions necessitating termination of an exercise session. Participants were instructed that the exercises would be effective only if they reached 60%-80% of the target heart rate, as determined by the Karvonen method, and 13-15 on the RPE. Diet-teaching program (using dietary education booklet).

Other: weekly telephone consultations concerning exercise and diet.

For each participant, we discussed exercise regimen-related issues and diet weekly through the telephone. For instance, we discussed whether participants' exercise fulfilled the prescribed intensity, duration, or frequency and whether the participants experienced any adverse effects.

No Intervention: usual-care group

The control group (CG) received usual care, whereas a nurse, the manager for esophageal cancer treatment, provided routine care, conducted follow-ups, and offered information on esophageal cancer to the experimental group (EG).

Outcome Measures

Primary Outcome Measures

Quality of life (EORTC QLQ-C30 ) [baseline]
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-C30 ) [3rd month after recruited]
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-C30 ) [6th month after recruited]
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-C30 ) [12th month after recruited]
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-C30 ) [24th month after recruited]
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-C30 ) [36th month after recruited]
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-OES 18 ) [baseline]
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-OES 18 ) [3rd month after recruited]
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-OES 18 ) [6th month after recruited]
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-OES 18 ) [12th month after recruited]
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-OES 18 ) [24th month after recruited]
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-OES 18 ) [36th month after recruited]
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.

Secondary Outcome Measures

Subjective sleep quality [baseline]
using Pittsburgh Sleep Quality Index
Subjective sleep quality [3rd month after recruited]
using Pittsburgh Sleep Quality Index
Subjective sleep quality [6th month after recruited]
using Pittsburgh Sleep Quality Index
Subjective sleep quality [12th month after recruited]
using Pittsburgh Sleep Quality Index
Subjective sleep quality [24th month after recruited]
using Pittsburgh Sleep Quality Index
Subjective sleep quality [36th month after recruited]
using Pittsburgh Sleep Quality Index
Objective sleep quality [baseline]
using Actigraph for measure Objective sleep quality
Objective sleep quality [3rd month after recruited]
using Actigraph for measure Objective sleep quality
Objective sleep quality [6th month after recruited]
using Actigraph for measure Objective sleep quality
Objective sleep quality [12th month after recruited]
using Actigraph for measure Objective sleep quality
Objective sleep quality [24th month after recruited]
using Actigraph for measure Objective sleep quality
Objective sleep quality [36th month after recruited]
using Actigraph for measure Objective sleep quality
Emotional distress [baseline, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited]
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Circadian rhythms [baseline, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited]
Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with esophageal cancer who were aged ≥20 years, could communicate in either Mandarin or Taiwanese, and were not cognitively impaired were included.

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taipei University of Nursing and Health Sciences	Taipei		Taiwan	112

Sponsors and Collaborators

Taipei Veterans General Hospital, Taiwan

Investigators

Principal Investigator: Hui-Mei Chen, PhD, National Taipei University of Nursing and Health Sciences
Principal Investigator: YU-CHUNG WU, M.D., Taipei Veterans General Hospital, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taipei Veterans General Hospital, Taiwan

ClinicalTrials.gov Identifier:

NCT03161535

Other Study ID Numbers:

2017-04-001A

First Posted:

May 22, 2017

Last Update Posted:

Oct 15, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Esophageal Neoplasms

Study Results

No Results Posted as of Oct 15, 2021